Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07793032

Experimental Validation of the Virtual Eggs Test (VET) in the Pediatric Population

Sponsor: IRCCS Fondazione Stella Maris

View on ClinicalTrials.gov

Summary

This study aims to investigate the validity of the Virtual Egg Test (VET) for the assessment of manual dexterity in children and adolescents with cerebral palsy and developmental coordination disorder (experimental group), including a typically developing group for the collection and establishment of normative values (control group). The clinical site where the study procedures for the experimental group will be conducted is the IRCCS Fondazione Stella Maris in Calambrone (Pisa), Italy. Participants of both sexes and of any ethnicity, aged between 6 and 21 years at the time of recruitment, will be selected according to specific inclusion criteria. The study protocol consists of two assessment sessions scheduled at an interval of at least 3 days and no more than 5 days. During the first assessment session (T0), standardized and non-standardized assessment procedures will be administered. First, the Virtual Egg Test (VET) will be administered using the Virtual Egg (VE). The VE is a parallelepiped-shaped device equipped with an internal magnetic mechanism that maintains the walls of the object in a predefined, non-collapsed position. When the grip force exceeds the attractive force between the two magnets, the external walls move closer together, causing the "VE to break" reversibly. The sensorized platform comprises three distinct sensitive areas: the starting position and two target areas for placing the VEs. The areas are separated by a 6-cm-high barrier. Subsequently, standardized clinical assessment tests will be administered. During the second assessment session (T1), the Virtual Egg Test (VET) will be administered, followed by a feasibility questionnaire specifically developed for this study regarding its use. The questionnaire will be completed by both the participant and the clinical staff.

Official title: Experimental Validation of the Virtual Eggs Test (VET) in Children and Young Adults With Cerebral Palsy and Developmental Coordination Disorder

Key Details

Gender

All

Age Range

6 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2026-09-01

Completion Date

2026-11-30

Last Updated

2026-08-28

Healthy Volunteers

Yes

Conditions

Cerebral Palsy (CP)Developmental Coordination Disorder (DCD)

Interventions

DEVICE

Virtual Eggs Test (VET)

The clinical study consists of one enrollment session and two testing sessions, scheduled 3-5 days apart for both the control group and participants with Cerebral Palsy or Developmental Coordination Disorder. During enrollment, eligibility is assessed and informed consent is obtained, and participant profiling data are collected. The first testing session varies by population. Control participants perform the Virtual Eggs Test (VET) with both dominant and non-dominant hands. Participants with Cerebral Palsy undergo the VET, Box and Block Test, Tyneside Pegboard Test, ABILHAND-Kids, and Monofilament Test. Participants with Developmental Coordination Disorder undergo the VET, Box and Block Test, Tyneside Pegboard Test, DCDQ'07, SDQ, Conners 3 Self-Report Scale, and Monofilament Test. The VET is always administered first. The second testing session consists exclusively of the VET with both hands, following the same administration order as the first session.

Inclusion Criteria: Inclusion Criteria - Cerebral Palsy Group * Diagnosis of Cerebral Palsy; * Participants of either sex and of any ethnicity, aged between 6 and 21 years at the time of recruitment; * MACS Level I-III (for participants with Cerebral Palsy); * BFMF Level I-IV (for participants with Cerebral Palsy); * House Functional Classification Level 4-8; * At least one cognitive index score \>70 on the WISC-IV, WISC-V, or WAIS-IV; * Participants who have provided informed consent, or for whom the legal guardian has provided informed consent and acknowledged receipt of the study information sheet. Inclusion Criteria - Developmental Coordination Disorder Group * Diagnosis of Developmental Coordination Disorder; * Participants of either sex and of any ethnicity, aged between 6 and 21 years at the time of recruitment; * Total mABC-2 score below the 15th percentile; * At least one cognitive functioning index score not lower than 2 standard deviations below the population mean, assessed using standardized tests performed within the previous 12 months, in order to ensure sufficient ability to understand and cooperate with the proposed activities; * Participants who have provided informed consent, or for whom the legal guardian has provided informed consent and acknowledged receipt of the study information sheet. Inclusion Criteria - Control Group * Participants of either sex and of any ethnicity, aged between 6 and 21 years; * Green zone on the mABC-2 Checklist; * Participants with cognitive and language abilities adequate to understand the experiment and follow instructions; * Participants who have provided informed consent, or for whom the legal guardian has provided informed consent and acknowledged receipt of the study information sheet. Exclusion Criteria: Exclusion Criteria - Cerebral Palsy and Developmental Coordination Disorder Groups * Participants with evident visual or oculomotor impairments; * Concomitant general or localized comorbidities/disabilities (e.g., multiple sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.) that may interfere with the ability to understand and perform the study protocol; * Presence of pathological cardiopulmonary or cardiovascular conditions; * Pregnancy or breastfeeding; * Insufficient level of cooperation. Exclusion Criteria - Control Group * Participants with evident visual or oculomotor impairments; * Concomitant general or localized comorbidities/disabilities (e.g., multiple sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.) that may interfere with the ability to understand and perform the study protocol; * Presence of pathological cardiopulmonary or cardiovascular conditions; * Pregnancy or breastfeeding; * Presence of psychiatric comorbidities; * Insufficient level of cooperation.

Locations (1)

IRCCS Fondazione Stella Maris

Calambrone, Pisa, Italy